There were numerous articles in February 2017 that covered a wide range of topical issues. Here are five of the best stories you might have missed… (click the headline to finish reading the story)
How to prepare for an FDA site inspection
For clinical trial sites, perhaps one of the most stressful events is preparing for an FDA inspection. Usually the sponsor’s Clinical Research Associate (CRA) is contacted by the Study Coordinator in a panic, notifying them that the FDA has called and they are scheduling their visit (usually on short notice as described in the FDA Bioresearch Monitoring Compliance Program Guidance Manual). The first questions for the site staff are whether it is indeed an FDA inspection, or perhaps an internal IRB audit or an audit by some Sponsor company? Is it OUR study that is being inspected, or perhaps a competitor’s? If we have multiple studies placed at this site, which study is being inspected? Did the FDA mention that the inspection is routine, or for cause?
Trump’s FDA deregulation could prove a poisoned chalice for Drugmakers
Uncertainty surrounding Donald Trump’s position on drug pricing and reform has evoked a nervous response from investors.
Pharma stocks suffered following comments on Jan. 11 that pharmaceutical companies are “getting away with murder,” and an implied threat that the ban on federal government negotiating drug prices for Medicare could be lifted.
Three weeks later, the newly inaugurated president had seemingly U-turned on his previous comments following a meeting with CEOs of Merck & Co., Novartis AG, Johnson & Johnson, Eli Lilly & Co., Celgene, and Amgen, as well as the head of PhRMA. He distanced himself from price controls, referring to it as price fixing:
It’s Not Me, It’s You: When Sponsor/Vendor Relationships go off the Rails
We’ve all been there. The bid defense meeting where we all get along so well, the kickoff meeting where the sponsor watches as their study, on which so much rides for their company, transfers into the hands of the newly chosen CRO, for better or for worse. We all worked hard on the request for proposal and the protocol, and the bid and its defense, and now we want to start ticking along according to the timelines.
But soon we begin to notice the timelines are starting to slip. Or resources we were expecting are not available. Startup tasks fall behind, contracts and submissions are delayed, money is wasted, investigators are upset and nerves are frayed.
How did we get here, how do we recover sufficiently to get good quality data, and what could we do to keep ourselves out of this predicament next time?
After Solanezumab failure, Eli Lilly let go of 485 Employees
After Eli Lilly’s Alzheimer’s disease (AD) drug, solanezumab, failed to meet its primary endpoint in their Phase III trial, the company now intends to cut close to 485 jobs in the US. Initially, it was hoped solanezumab would become the first disease-modifying drug for AD, with the prospect of it generating billions of dollars in sales. Nevertheless, the drug’s failure will force Eli Lilly’s hand in shuttering its US-based Alzheimer’s unit in Indianapolis, IN. It will also necessitate the need for the company to reassess assets currently in the pipeline.
With Solanezumab long having led the way in the race to become the first treatment to reverse or halt AD, the drug’s failure will come as a huge blow for AD research. The Phase III trial, EXPEDITION-3, was a 39-center study treating 2,100 patients with mild AD, which was initiated despite the fact solanezumab had failed two large Phase III trials (EXPEDITION-1 and -2) in 2012. Eli Lilly’s gamble to continue the trial and retest the drug in mild AD patients resulted once again in a disappointment, which will have a serious ramification for Eli Lilly, as the company still has six AD products in its pipeline with a similar mechanism of action: targeting amyloid-beta.
Exploring the key considerations for Direct-to-Patient shipping
For patients who can’t make it in to the clinical sites themselves, direct-to-patient shipments is a new method of clinical trial shipment which could prove invaluable to patients who want to participate within clinical trials, but are too ill to make the journey to the trial site. Involving the drug being shipped right to the patient’s front door, it could prove a method that will solve many of the current recruitment shortfalls, and is a method logistic giants, such as World Courier and DHL Supply Chain, are already making strides. However, alongside the rise of such an innovative supply method, are issues relating to the storage of medical supplies within homes. For example, there are new regulations around this process which, as of yet, have not been completely considered. One such issue is the storage of temperature sensitive supplies, and biologics. With the thermo-unstable category on the rise, it is crucial we keep the stability of the molecules and maintain a constant temperature to ensure the supplies don’t spoil.
PHOTO CREDIT: Rob Nguyen